LONDON – GSK plc (LSE/NYSE: GSK) has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its investigational drug GSK'227, which aims to treat adults with relapsed or refractory osteosarcoma who have not responded to at least two previous treatments. This designation aims to accelerate the development and review of drugs that could significantly improve the treatment of severe cases.
The decision is supported by data from the ARTEMIS-002 study, a phase 2 clinical trial evaluating the efficacy and safety of GSK'227 in patients with osteosarcoma. The trial, which included more than 60 participants with various bone and soft tissue sarcoma tumors, showed promising early results, especially for the 42 patients with osteosarcoma.
GSK'227 is a B7-H3-targeting antibody complex (ADC) that delivers topoisomerase inhibitor payload directly to cancer cells. The drug has also received regulatory designations from the European Medicines Agency and the Food and Drug Administration for its potential in treating extensive small-cell lung cancer.
Osteosarcoma is a rare and aggressive bone cancer that mostly affects children and young adults. It accounts for 20-40% of all bone cancer cases, and the annual incidence is 3.3 patients per million in the United States. Treatment options for those with relapsed or refractory osteosarcoma are limited, especially after failure of two lines of treatment, highlighting the urgent need for new treatment options.
GSK, known for its focus on oncology and commitment to improving patient survival, has acquired exclusive worldwide rights to further develop and commercialize GSK'227, with ongoing global trials.
This announcement is based on a GSK press release.
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